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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00234884
Registration number
NCT00234884
Ethics application status
Date submitted
16/09/2005
Date registered
10/10/2005
Date last updated
30/09/2011
Titles & IDs
Public title
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
Query!
Scientific title
A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira
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Secondary ID [1]
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0
M03-634
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Universal Trial Number (UTN)
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Trial acronym
ReAlise
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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0
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - adalimumab
Adalimumab - RA patients in treatment with commercial adalimumab
Other interventions: adalimumab
commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)
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Assessment method [1]
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DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.
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Timepoint [1]
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Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
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Primary outcome [2]
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American College of Rheumatology 20% (ACR20) Response Rate
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Assessment method [2]
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ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
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Timepoint [2]
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Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
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Primary outcome [3]
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American College of Rheumatology 50% (ACR50) Response Rate
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Assessment method [3]
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ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
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Timepoint [3]
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Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
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Primary outcome [4]
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American College of Rheumatology 70% (ACR70) Response Rate
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Assessment method [4]
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ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
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Timepoint [4]
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Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
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Primary outcome [5]
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Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
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Assessment method [5]
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HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).
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Timepoint [5]
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Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
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Eligibility
Key inclusion criteria
- Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit
5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab
according to the Summary of Product Characteristics (SmPC).
- Participants must have been willing to consent to data being collected and provided to
Abbott.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
· Participants with contraindications according to the SmPC.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2010
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Sample size
Target
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Accrual to date
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Final
3435
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Site Ref # / Investigator 5606 - Camperdown
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Recruitment hospital [2]
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Site Ref # / Investigator 49504 - New Lambton
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Recruitment hospital [3]
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Site Ref # / Investigator 49508 - Brisbane
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Recruitment hospital [4]
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Site Ref # / Investigator 49505 - Woodville
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Recruitment hospital [5]
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Site Ref # / Investigator 49503 - West Heidelberg
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Recruitment hospital [6]
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Site Ref # / Investigator 49502 - Cairns
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2305 - New Lambton
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment postcode(s) [5]
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3081 - West Heidelberg
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Recruitment postcode(s) [6]
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4870 - Cairns
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Recruitment outside Australia
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Austria
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Bad Schallerbach
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Austria
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Graz
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Austria
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Klagenfurt
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Laab im Walde
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Germany
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Hamburg
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Country [132]
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Germany
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Hattingen
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Germany
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Herrsching
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Germany
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Hildesheim
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Germany
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Hofheim
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Germany
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Jena
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Germany
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Leipzig
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Germany
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Ludwigsburg
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Germany
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Ludwigshafen
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Germany
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Marl
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Germany
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Moenchengladbach
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Germany
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Muenster
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Germany
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Munich
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Germany
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Passau
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Germany
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Ratingen
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Country [146]
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Germany
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Rostock
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Germany
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Schlangenbad
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Country [148]
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Germany
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State/province [148]
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Sendenhorst
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Germany
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Stuttgart
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Germany
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Tuebingen
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Germany
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Villingen
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Country [152]
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Germany
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Vogelsang-Gommern
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Germany
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Wuerzburg
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Germany
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Wuppertal
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Larisa
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Greece
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Patras
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Country [160]
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Greece
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State/province [160]
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Thessaloniki
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Country [161]
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Italy
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Acqui Terme (AL)
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Italy
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Arenzano (GE)
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Country [163]
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Italy
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State/province [163]
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Bari
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Country [164]
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Italy
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State/province [164]
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Bologna
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Country [165]
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Italy
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State/province [165]
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Brescia
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Country [166]
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Italy
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State/province [166]
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Cagliari
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Country [167]
0
0
Italy
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State/province [167]
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Ferrara
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Country [168]
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Italy
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State/province [168]
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Florence
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Country [169]
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Italy
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State/province [169]
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Foggia
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Country [170]
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Italy
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State/province [170]
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Genoa
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Country [171]
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Italy
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State/province [171]
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Jesi (Ancona)
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Country [172]
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Italy
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State/province [172]
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Messina
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Country [173]
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Italy
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State/province [173]
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Milano
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Country [174]
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Italy
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State/province [174]
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Modena
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Country [175]
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Italy
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State/province [175]
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Naples
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Country [176]
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Italy
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State/province [176]
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Novara
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Country [177]
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Italy
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Padova
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Country [178]
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Italy
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Palermo
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Country [179]
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Italy
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State/province [179]
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Perugia
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Country [180]
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Italy
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State/province [180]
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Pescara
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Country [181]
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Italy
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Pisa
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Country [182]
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Italy
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Potenza
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Country [183]
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Italy
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State/province [183]
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Prato
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Country [184]
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Italy
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State/province [184]
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Reggio Emilia
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Country [185]
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Italy
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Rome
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Country [186]
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Italy
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Rozzano
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Country [187]
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Italy
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San Cesario Lecce
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Country [188]
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Italy
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Torino
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Country [189]
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Italy
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State/province [189]
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Udine
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Country [190]
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Italy
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Valeggio sul Mincio Verona
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Country [191]
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Italy
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State/province [191]
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Varese
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Country [192]
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Italy
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State/province [192]
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Verbania Pallanza
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Country [193]
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0
Italy
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Verona
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Country [194]
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0
Italy
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State/province [194]
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Vimercate
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Country [195]
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0
Netherlands
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Alkmaar
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Country [196]
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0
Netherlands
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State/province [196]
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Almere
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Country [197]
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0
Netherlands
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State/province [197]
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Amersfoort
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Country [198]
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Netherlands
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State/province [198]
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Bergen op Zoom
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Netherlands
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State/province [199]
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Breda
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Country [200]
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Netherlands
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Den Haag
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Country [201]
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0
Netherlands
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Den Helder
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Country [202]
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0
Netherlands
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State/province [202]
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0
Goes
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Country [203]
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0
Netherlands
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Leeuwarden
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Country [204]
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0
Netherlands
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Rotterdam
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Country [205]
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0
Netherlands
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Schiedam
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Country [206]
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Netherlands
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Utrecht
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Country [207]
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0
Netherlands
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State/province [207]
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Venlo
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Country [208]
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0
Netherlands
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State/province [208]
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Vlissingen
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Country [209]
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Portugal
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State/province [209]
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Coimbra
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Country [210]
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0
Portugal
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State/province [210]
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Lisboa
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Country [211]
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Portugal
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State/province [211]
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Lisbon
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Country [212]
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0
Portugal
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State/province [212]
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Ponta Delgada-Acores
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Country [213]
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0
Portugal
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State/province [213]
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Ponte de Lima
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Country [214]
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0
Spain
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Alicante
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Country [215]
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Spain
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Asturias
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Country [216]
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Spain
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Barcelona
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Country [217]
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0
Spain
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State/province [217]
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Cadiz
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Country [218]
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Spain
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Castellon de la Plana
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Country [219]
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Spain
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Cordoba
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Country [220]
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Spain
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Elche
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Country [221]
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0
Spain
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Granada
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Country [222]
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0
Spain
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Guadalajara
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Country [223]
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Spain
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Jaen
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Country [224]
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Spain
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State/province [224]
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Lerida
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Country [225]
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Spain
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Madrid
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Spain
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Malaga
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Country [227]
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Spain
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State/province [227]
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Mostoles-Madrid
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Country [228]
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Spain
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State/province [228]
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Sant Joan Despi (Barcelona)
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Country [229]
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Spain
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Seville
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Country [230]
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Spain
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Toledo
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Country [231]
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Spain
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State/province [231]
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Valencia
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Country [232]
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Spain
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State/province [232]
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Vic (Barcelona)
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Country [233]
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United Kingdom
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State/province [233]
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Brighton
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Country [234]
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0
United Kingdom
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State/province [234]
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0
Greater Manchester
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Country [235]
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0
United Kingdom
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Harrogate
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Country [236]
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0
United Kingdom
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Manchester
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Country [237]
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0
United Kingdom
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Oxford
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Country [238]
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0
United Kingdom
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State/province [238]
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0
Wigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this observational study was to observe and assess the long term use, safety,
and effectiveness of adalimumab in a normal clinical setting.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00234884
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Laura Redden, MD, PhD
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Address
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0
Abbott
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Country
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0
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Phone
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0
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Fax
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0
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00234884
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